Regulatory Compliance: Summary The Regulatory Compliance group functions primarily as an independent Quality Assurance Unit (QAU) providing oversight of all research functions in nonclinical studies as required by United States Food and Drug Administration (FDA) Code of Federal Regulations chapter 21 part 58 (21 CFR Part 58). To serve in this capacity, the Regulatory Compliance interim Core Director is coordinating the development and identifying the elements of the pathway required to get the relevant necessary Cores in the NEIDL prepared to work in a Well Documented and GLP environment. The specific aims of this core are to: 1) Monitor Well Documented and GLP studies for accuracy and integrity of any data generated in such studies; 2) Conduct relevant Well Documented and GLP compliance training for core directors and key staff; 3) Develop policies and procedures pertaining to the Quality Assurance Unit; 4) Provide advice and oversight for equipment procurement and facility commissioning activities. The Regulatory Compliance group will work in conjunction with the Study Director and Integrated Support Services Cores to coordinate all research functions in support of Study Protocols for Well Documented and GLP studies.